Submit Monographs and Revisions

Participation in USP's public standards-setting process by the pharmaceutical industry and other stakeholders is vital to the development of authoritative, relevant USP–NF monographs. Interested parties can participate in any of the following ways:

• Submit new draft monographs for complex and noncomplex drug substances and dosage forms
• Review and comment on draft monographs published in the Pharmacopeial Forum
• Propose revisions to monographs and procedures in the current official edition of USP–NF and submit data for proposed alternatives
• Share with USP concerns regarding public comments on proposed new monographs and revisions published in the Pharmacopeial Forum

Submit New Monographs

USP encourages you to submit draft monographs for your non-complex and complex drug substances and dosage forms as well as excipients. Your draft monograph will become the starting point for the official public standard. USP staff will involve you in a process of public review and comment to refine and finalize these monographs for publication in the USP–NF. See a priority list of items for which USP requires monographs.

Monograph Submission Guidelines

To review Monograph Submission Guidelines, click here. USP would like you to include the following information in draft monographs that you submit:

• The United States Adopted Name of the drug product
• Identification procedures
• Water correction procedure, where appropriate
• Stability-indicating assay

Please submit your draft monographs or email your questions on submission to Karen A. Russo, Ph.D., .

Additional Requirements for Active Substances

• Heavy metals
• Organic volatile impurities
• Acceptance criteria for process impurities
• Acceptance criteria for degradation products
• Physical property check procedures

Additional Requirements for Dosage Forms

• Release testing, where appropriate
• Limits for degradation compounds
• Uniformity of dosage units
• Sterility
• Bacterial endotoxins, where appropriate

Download a PDF of the complete monograph submission and revision guidelines.